Chapter 3 discusses the basic IRB process and is especially relevant to graduate students and their advisors. It concludes with issues of interest to only a few investigators.
University policy specifies that any research involving human subjects must be approved by the Institutional Review Board". Whether this provision applies to you is based on your answers to two questions:
- Is your study a systematic investigation designed to develop or contribute to the body of generalizable knowledge? If yes, then your study is defined as research.
- Will you obtain data through investigation or interaction with one or more living individuals, or will you obtain any identifiable private information about a living individual? If yes, then you are using human subjects.
If you answered yes to both questions, then your study is defined as research with human subjects and must be approved by the IRB before you begin recruitment of research participants or data collection. Please note that survey research, all pilot studies, and oral history research do meet this definition and must be approved by the IRB before you send out questionnaires, interview subjects, or otherwise have contact with potential subjects.
Prior IRB approval is mandated by Federal Law and by policy of The University of Mississippi.
Research: A systematic investigation designed to develop or contribute to generalizable knowledge [45CFR 46.102(l)]. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Some research development or testing and evaluation may also meet this definition.
Human subjects : A living individual about whom an investigator conducting research obtains (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or, (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45CFR 46.102(e)]
Note: Investigators should begin to consider IRB issues during the planning stages of a research project. One should consider issues such as subject selection, the use of deception, and the collection of sensitive data. When possible the investigator should try to eliminate the need for these higher risk procedures. When it is not possible to eliminate these risks the investigator must demonstrate the need for such high risk procedures and take steps to minimize the potential risk to the subject.